VA reporting requirements generally parallel reporting requirements for non-VA studies, with the exception of timeframe for report. Any event that occurs on a study under Madison VA purview that meets UW unanticipated problem or noncompliance reporting requirements must be reported to the IRB and Associate Chief of Staff within 5 business days of the local research team becoming aware of the event.

Any local research death that is both unanticipated AND related to the research must be orally reported to the IRB immediately after the local research team becomes aware of the death. Written notification of the death must be received by the IRB within 5 business days of the local research team becoming aware of the death.